FDA now requires suicide assessment of new drugs prior to approval

Mark Dombeck, Ph.D. was Director of Mental Help Net from 1999 to 2011.
Dr. Dombeck received his Ph.D. in Clinical Psychology in 1995...Read More

For many years, the Food and Drug Administration (FDA) has served a screening role to help insure the safety of new drugs coming on to the United States health care market. Simply put, the FDA must approve drugs for sale and approve them for specific uses before they can be legally sold in the United States. The FDA doesn’t do it’s own evaluation of drug safety, however. Instead, it requires that the pharmaceutical companies evaluate the safety of their own new drugs, albeit according to strict research guidelines and rules. You’d think that this is like asking the fox to watch the hen house, and in many ways it is like that. Pharmaceutical companies are, for instance, seemingly free to run as many studies as they like and to ignore the ones that fail to show positive effects or which otherwise make the drugs they are evaluating look bad. Drugs don’t get approval if no studies demonstrate that the drugs work, however, and drugs are also not approved when unsafe side effects are noted. It’s a flawed system, but it isn’t all bad.

Apart from the fact that the company with a vested interest in getting drugs approved is running the show regarding the approval testing process, which is a killer flaw, if you ask me, there are other flaws in how the approval process occurs. One of them has to do with how broadly drugs are tested for dangerous side-effects. For instance, many drugs are not routinely tested for safety when used with child and elder populations. Also, many drugs are not routinely tested to see if they create subtle changes in behavior (rather than obvious physical changes) which might cause people to develop mental illness style side effects such as heightened suicidal ideation and suicidal urges. This was the case with antidepressants and children not so long ago when it became known that some antidepressant medications were associated with heightened suicide risk. The FDA responded by issuing a mandate that such medications carry a black box warning detailing the possibility of suicidal side effects. A warning is a good thing, but the agency can do better. Today, the New York Times is reporting another step the FDA is taking to improve drug safety, namely to require that new drug evaluations routinely include an evaluation of suicide symptoms.

The scale that the FDA is requiring, by the way, is (as far as I can tell) the Columbia-Suicide Severity Rating Scale (C-SSRS), developed by Columbia Psychologist Kelly Posner, Ph.D. A copy of the scale (not sure it is the latest version) appears to be available online in this Powerpoint file between slides 20 and 23. I’ve created a PDF version of the relevant pages for those who don’t have Powerpoint but still want to see the document. Nothing complex there. It’s essentially a systematic interview that goes step by step through various ways that suicidal issues present themselves. Symptoms are either present or not. It’s not exactly rocket science but it will do.

This is certainly a good development and should help to improve the safety of future drugs that go on the American market, at least as far as suicide goes. A whole lot more could be done, of course. Candidate drugs could be evaluated across a fuller spectrum of possible dangerous side effects both physical and mental for one thing. They could be evaluated for use with children and the elderly a lot more rigorously as well. The FDA gets around the problem with regard to safety with child populations by simply not including use with that population when it makes its approval. However, this amounts to a legal fiction on the part of the FDA; a bit of liability shifting. Doctors are not prevented from using medications "off label" (e.g., in ways that the FDA has not specifically approved) and in some cases there are no medications which are known to work with children who nevertheless would benefit from medication in the eyes of doctors. So children end up getting the medications anyway even though they have not been approved for use with children. The whole approval process is political as you might imagine and very likely subject to influence peddling. I’m not sure what is realistic to expect with regard to tighter and tighter regulations, but today’s announcement is certainly welcome.

Philip over at Furious Seasons has written about this issue today in his characteristically detailed, readable and somewhat sarcastic manner. It’s worth a read.

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